E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertension in acute stroke |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• Effects of GTN on BP at 2 hours post treatment. [This outcome represents the sum of the trial, i.e. ability to identify, recruit, randomise, treat, and make measurements in patients presumed stroke in an ambulance, and hand them over to hospital staff. The 2 hour time reflects the time to peak effect for GTN.] |
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E.2.2 | Secondary objectives of the trial |
•Proportions of patients i) randomised:approached about joining; ii) randomised:carried in ambulance; iii) treated according to protocol:all randomised (diagnostic accuracy); iv) reasons for not enrolling •Times from ictus to randomisation in ambulance; ictus to ED arrival, randomisation to ED arrival •Paramedics: Interview on experience and views; audit of routine care •Haemodynamic effects of GTN: on BP, HR and derivatives prior to ED arrival and at 2 hours •SSS at 2 hours; daily BP/HR/PP/RPP over 7 days; rates of headache, hypotension/hypertension needing intervention •Death; SSS; death/deterioration; recurrence-progression; symptomatic intracranial events; major extracranial haemorrhage; final diagnosis •Length of stay in hospital; discharge disposition. 90 days: Death; death or dependency mRS>2; disability Barthel Index; quality of life EuroQoL; cognition MMSE; mood Zung; •To assess the effects of GTN on surrogate marker of efficacy in the blood |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients; >40 years of age • Paramedic assessment of stroke on basis of positive ‘Face & Arm weakness & Speech abnormality Test (FAST) in the context of a call to a patient with a ‘possible acute stroke’; • Event <4 hours of onset (sleep stroke - onset as bed time); • High systolic BP (>140 mmHg). |
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E.4 | Principal exclusion criteria |
• No consent/assent is available • GTN is indicated (e.g. concurrent angina) • GTN is contraindicated (e.g. dehydration, hypovolaemia); • Age <40 years;30 • Coma; GCS ≤8 • History of seizures30 • Non-ambulatory pre-morbidly (modified Rankin scale of >2)30 • Hypoglycaemia (if glucose tested). • Patients from a nursing home |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |